A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

NCT ID: NCT01979653

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under spinal anesthesia.

Detailed Description

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Conditions

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Sedation; Aged; Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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dexmedetomidine alone

dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion

Group Type EXPERIMENTAL

dexmedetomidine alone or dexmedetomidine + midazolam

Intervention Type DRUG

dexmedetomidine + midazolam

normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion

Group Type EXPERIMENTAL

dexmedetomidine alone or dexmedetomidine + midazolam

Intervention Type DRUG

Interventions

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dexmedetomidine alone or dexmedetomidine + midazolam

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* aged ≥ 65 years
* ASA physical status class I-II
* the patients who want sedation during elective lower limb surgery under spinal anesthesia

Exclusion Criteria

* contraindication to spinal anesthesia
* neurologic or cognitive dysfunction
* severe cardiovascular or pulmonary disease
* refusal to participation
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2013-0615

Identifier Type: -

Identifier Source: org_study_id

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